Trial · NCT02582996
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain relief of Cefalium® compared to Tylenol® | 2 hours | Relief of pain 2 hours after taking medication, being considered to reduce the intensity from strong(3) or moderate(2), at baseline, to mild(1) or absent(0) 2 hours after taking the medication, according to the functional and behavioral debilitating categorical scale without use of rescue medication as annotations the diary of symptoms |
| Secondary | Pain decrease after use of investigational product, without a rescue medication | Up to 4 hours | Number of participants with pain decrease in 2 hours and 4 hours after the use of the investigational product,at the first migraine attack with mild or moderate pain, with remission defined as no pain (0) in categorical scale debilitating functional and behavioral (4 point-scale), without use of a rescue medication |
| Secondary | Pain decrease after use of the investigational product, without a rescue medication | 4 hours | Number of participants with pain relief in 4 hours after the use of the investigational product, in the first migraine attack with mild or moderate pain,and is considered the relief reduction of at least 01 point in pain intensity from baseline, according to functional and behavioral debilitating categorical scale without use of a rescue medication; |
| Secondary | Pain relief maintenance during the period 4-24 hours after use of investigational product | Up to 24 hours | The maintenance will be observed if the relief reached the first 4 hours will remain at 24 hours after use of the investigational product, according to functional and behavioral debilitating categorical scale (4 point scale) without use of rescue medication during this period; |
| Secondary | Nausea/vomiting Symptoms Free | Up to 4 hours | Participants free of nausea/vomiting symptoms 2 and 4 hours after use of investigational product,at the first migraine attack of moderate to severe pain intensity, defined as the proportion of subjects with no symptoms of both among the participants have at least one symptom at baseline of migraine without use of a rescue medication during this period. |
| Secondary | Photophobia/Phonophobia Symptoms Free | Up to 4 hours | Participants free of photophobia/phonophobia symptoms 2 and 4 hours after use of investigational product, at the first migraine attack of moderate to severe pain intensity, defined as the proportion of subjects with no symptoms of both among the participants have at least one symptom at baseline of migraine without use of a rescue medication during this period. |
| Secondary | Need of a rescue medication | Up to 24 hours | Number of participants who use at least once the rescue medication in a 2-24 hours period after use of the investigational product. |
| Other | Variation in laboratory exams ratings | From baseline visit until 30 days after the end of the treatment | Number of participants with any relevant variation in laboratory exams from baseline visit until 30 days after the end of the treatment |
| Other | Variation in clinical exams ratings | From baseline visit until 30 days after the end of the treatment | Number of participants with any relevant variation in clinical exams from baseline visit until 30 days after the end of the treatment |
| Other | Variation in physical exams ratings | From baseline visit until 30 days after the end of the treatment | Number of participants with any relevant variation in physical exams from baseline visit until 30 days after the end of the treatment |
| Other | Participants with adverse events | From baseline visit until 30 days after the end of the treatment | Number of participants with any adverse events from baseline visit until 30 days after the end of the treatment |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT02582996/registered